Positive-air-pressure machine conduit

ABSTRACT

A conduit for delivering a supply of gas under a positive pressure includes a conduit wall having a first conduit end and a second conduit end. The first conduit end is adapted to be attached to the supply of gas. The conduit wall is deformable between (a) an open condition in which the conduit wall defines a conduit passage along which the supply of gas can travel between the first conduit end to the second conduit end, and (b) a collapsed condition in which the conduit wall substantially collapses the conduit passage.

CROSS-REFERENCE TO APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 11/578,293, filed Oct. 13, 2006, which was the US national phase ofinternational application PCT/AU2005/000539 filed Apr. 15, 2005, whichdesignated the U.S. and claimed the benefit of AU 2004902020 filed Apr.15, 2004, the entire contents of each of which is hereby incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates to a positive-air-pressure (PAP) machineconduit. The present invention also relates to headgear including such aconduit and to nose pieces including such a conduit.

BACKGROUND OF THE INVENTION

One of the main factors influencing the success or failure of a patientto adopt a CPAP apparatus used in the treatment of obstructive sleepapnea is the patient's ability to handle the discomfort of the headgearand supply conduit associated with such apparatus.

Such apparatus can tend to limit a patient's ability to move or rollduring sleep, thus adding to the potential discomfort for a patient.

Therefore, a need has developed in the art to overcome or ameliorate atleast some of the disadvantages of such apparatus, or to provide auseful alternative.

SUMMARY OF THE INVENTION

One aspect of the invention relates to a conduit for delivering a supplyof gas under a positive pressure. The conduit includes a conduit wallhaving a first conduit end and a second conduit end. The first conduitend is adapted to be attached to the supply of gas. The conduit wall isdeformable between (a) an open condition in which the conduit walldefines a conduit passage along which the supply of gas can travelbetween the first conduit end to the second conduit end, and (b) acollapsed condition in which the conduit wall substantially collapsesthe conduit passage.

Another aspect of the invention relates to headgear for delivering asupply of gas under a positive pressure to a patient. The headgearincludes a connector adapted to be attached to the supply of gas. A pairof side portions are adapted to extend along opposite sides of thepatient's head. Each of the side portions defines a conduit having afirst conduit end attached to the connector and a second conduit endadapted to be positioned adjacent the patient's nose. A head attachmentstructure is adapted to releasably secure the headgear to the patient'shead.

Another aspect of the invention relates to a nasal assembly fordelivering a supply of gas under a positive pressure to a patient. Thenasal assembly includes a connector adapted to be attached to the supplyof gas, a nose-piece adapted to engage the patient's nose, and a pair ofside portions adapted to extend along opposite sides of the patient'shead. Each of the side portions defines a conduit having a first conduitend attached to the connector and a second conduit end adapted toconnect to the nose-piece. A head attachment structure is adapted toreleasably secure the headgear to the patient's head.

Another aspect of the invention relates to a method for using a conduitto deliver a supply of gas under a positive pressure. The methodincludes providing a conduit including a conduit wall having a firstconduit end and a second conduit end. The conduit wall is deformablebetween (a) an open condition in which the conduit wall defines aconduit passage along which the supply of gas can travel between thefirst conduit end to the second conduit end, and (b) a collapsedcondition in which the conduit wall substantially collapses the conduitpassage. The method includes connecting the first conduit end of theconduit to the supply of gas, delivering the supply of gas into theconduit via the first conduit end such that the supply of gas urges theconduit wall into the open condition to allow the supply of gas totravel from the first conduit end to the second conduit end, anddisposing the second conduit end of the conduit at a position at whichthe supply of gas is to be delivered.

Another aspect of the invention relates to a method for constructingheadgear that delivers a supply of gas under a positive pressure to apatient. The method includes providing headgear including at least oneconduit that defines a conduit passage along which the supply of gas cantravel, mapping the shape of a particular patient's head, and formingthe headgear into a headgear shape in accordance with the mapping suchthat the headgear achieves a substantially close and comfortable fit onthe particular patient's head.

Another aspect of the invention relates to a positive-air-pressure (PAP)machine conduit. The conduit includes flexible conduit walls, a firstconduit end adapted for attachment to a supply of gas under a positivepressure, and a second conduit end. The conduit is configured such thatwhen the first end is connected to the supply, the gas urges the conduitwalls into a first condition in which the walls define a conduit passagealong which the gas travels from the first end to the second end. Theconduit is deformable into a second condition in which the passage issubstantially collapsed.

In an embodiment, the conduit may be formed from a single piece of sheetmaterial.

In another embodiment, the conduit may be formed from at least twopieces of sheet material which are joined together.

In another embodiment, the conduit may be formed from woven sheetmaterial. In yet another embodiment, the conduit may be formed fromflexible polymeric sheet material, which in an embodiment may be anelastic material.

In another embodiment, the material may a lamination of a plurality ofmaterials. In forms of this embodiment, the material may be a laminationof a thin foam layer and a fabric layer which, in one form, is coated onthe foam layer, or felt flocking which, in one form, is coated on thefoam layer. Such embodiments may provide a soft, warm comfortable feelagainst the skin of a patient using the conduit.

In another embodiment, parts of the conduit which are adapted to be incontact with the skin of a patient may be of gel-like material.

In yet another embodiment, the conduit walls may be configured to permitthe leaking of gas therethrough from the passage.

In yet another embodiment, the conduit walls may include wall portionsin the form of double walls defining a substantially gas tight spacebetween them.

In still another embodiment, the conduit walls may be substantiallydevoid of elasticity. In another embodiment, the conduit walls may haveelasticity so as to be expandable. In yet further embodiments, theconduit walls may have at least one region with elasticity and at leastone other region substantially devoid of elasticity, and/or differentregions of differing amounts of elasticity.

Another aspect of the invention relates to a positive-air-pressure (PAP)headgear. The headgear includes connection means for connection influid-flow communication to a supply of gas configured for providing gasunder a positive pressure and a pair of conduits according toabove-noted aspects of the invention or embodiments thereof. Theconduits are configured to extend around opposite sides of a patient'shead. The first end of each conduit is connected in fluid-flowcommunication to the connection means and the second end of each conduitis configured, when the headgear is being worn by the patient, to bepositioned adjacent the patient's nose. Head attachment means releasablysecures the headgear to the patient's head.

In an embodiment, the second end may be configured to be connected to anose-piece for directing gas that has passed along the passages from thesecond ends to within the patient's nose.

In another embodiment, the headgear may be configured, when the headgearis being worn by the patient, for the conduits to extend across thepatient's nose. The headgear may define a pair of apertures opening intothe conduits and positioned to be adjacent the patient's nose forattachment of at least one nose-piece for directing gas that has passedalong the passages to within the patient's nose.

In this case, in one embodiment, the second ends may be integrallyjoined to each other.

Also in this case, the headgear may be provided with a pair of sealrings, each joined to the headgear at a respective aperture forestablishing a close seal with the at least one nose-piece.

In another embodiment, the material from which each conduit is formedmay be adapted to permit the passage of water vapour therethrough toenhance patient comfort particularly in a warm climate, but issubstantially air tight.

In another embodiment, the head attachment means may include a strapjoined to at least one of the pair of conduits.

In another embodiment, the pair of conduits and at least part of theconnection means may be integral with one another in a unitaryconstruction.

In another embodiment, the pair of conduits, at least part of theconnection means, and the strap are integral with one another in aunitary construction.

In yet another embodiment, the headgear may be configured such that thestrap extends around a portion of the head posterior to the apex.

In yet another embodiment, the headgear may be configured such that,when the headgear is being worn by the patient, the connection means maybe disposed at a position adjacent to or anterior of the apex of thepatient's head.

In an embodiment, the headgear may be configured such that, when theconnection means is connected in fluid-flow communication to a supply ofgas with the supply of gas providing gas under a positive pressure sothat the gas travels along the pair of conduits, collapsing of thepassage of one of the conduits due to compression being applied to thatconduit, which collapsing results in a decrease in the volume flow rateof gas through that passage, results in a deformation of the passage ofthe other conduit and an associated increase in volume flow rate of gasthrough the passage of that other conduit.

The headgear may be configured such that, as a result of the deformationof the passage of the other conduit, the total volume flow rate of thegas through the pair of conduits remains substantially constant duringthe collapsing of the passage of the one conduit.

In an embodiment, the collapsing of the passage of the one conduit isdeformation which causes a change in the ratio between a height extentand a lateral extent of that passage. In one embodiment, the heightextent decreases and the lateral extent increases. Similarly, in anotherembodiment, the deformation of the passage of the other conduit isdeformation which causes a change in the ratio between a height extentand a lateral extent of that passage. In one embodiment, the heightextent increases and the lateral extent decreases.

In another embodiment, the headgear may include an adjustable head capwith the conduits being attached to the cap at opposite sides thereof.In this case, the cap may constitute the attachment means, and theconnection means may be mounted on the cap.

In yet another embodiment, the conduits may be detachable from theattachment means so that the attachment means may be selectivelyreleasably connected with differently sized and/or shaped conduits. Inthis case, the conduits may be selectively releasably connected withdifferently sized and/or shaped attachment means, whereby the headgearmay form part of a modular headgear system having interchangeableattachment means and conduits.

In an embodiment, the headgear may be adapted for use with a patientmask configured to fit the patient's head adjacent the patient's nose todirect gas from the conduits to the nose. Then, the headgear may beadapted to be detachable from the mask to enable the patient toselectively remove the mask from the headgear and hence from thepatient's head while the headgear continues to be being worn by thepatient.

Yet another aspect of the invention relates to a nose-piece configuredfor attachment to a headgear, according to above-noted aspects of theinvention or embodiments thereof, for directing air from the second endof a conduit to the interior of the patient's nose.

In an embodiment, the nose-piece may include a conduit according toabove-noted aspects of the invention or embodiments thereof.

In another embodiment, the flexible conduit walls may be double wallsdefining a substantially gas-tight space between them.

In another embodiment, the nose-piece may include a nozzle opening intothe space to enable the delivery of gas into the space to inflate thenose-piece.

In another embodiment, the nose-piece may be a conduit according toabove-noted aspects of the invention or embodiments thereof.

In another embodiment, the nose-piece may include a pair of nostrilformations for being received in a patient's nose and for directing gasfrom the conduit passage into the nose. Then, in an embodiment, theconduit may define a pair of nostril formation apertures, each nostrilformation extending through a respective nostril formation aperture.

In another embodiment, the nostril formations may be customized toclosely fit the nostrils of a particular patient.

In yet another embodiment, parts of the headgear which are adapted to bein contact with the skin of a patient may be of gel-like material.

Still another aspect of the invention relates to a method of using a PAPmachine conduit, according to above-noted aspects of the invention orembodiments thereof, for delivering air. The method includes connectingthe first end of the conduit to a supply means configured for supplyingair under a positive pressure, delivering air by the machine to theconduit via the first end such that the air urges the conduit walls intothe first condition, and disposing the second end at a position at whichthe air is to be delivered such that the air that has passed along thepassage exits the conduit at the second end.

Still another aspect of the invention relates to a method of providing aPAP headgear for use by a particular patient. The headgear includesconnection means for connection in fluid-flow communication to a supplyof gas configured for providing gas under a positive pressure, a pair ofconduits configured to extend around opposite sides of the particularpatient's head, and head attachment means to releasably secure theheadgear to the particular patient's head. Each conduit has flexibleconduit walls, a first conduit end connected in fluid-flow communicationto the connection means, and a second conduit end configured, when theheadgear is being worn by the particular patient, to be positionedadjacent the particular patient's nose. Each conduit is configured suchthat when the connection means is connected to the supply, the gas urgesthe conduit walls into a first condition in which the walls define arespective conduit passage along which the gas travels from therespective first end to the respective second end and wherein eachconduit is compressibly deformable into a second condition in which thepassage is substantially collapsed. The method includes mapping theshape of the particular patient's head, and forming the headgear into aheadgear shape in accordance with the mapping such that the headgear,when fitted to the particular patient's head, is a close fit thereon.

In an embodiment, the method may include after mapping the shape of theparticular patient's head, forming a head template in accordance withthe mapping. Also, the forming the headgear into a headgear shape mayinclude forming the headgear in accordance with the shape of thetemplate.

In another embodiment, the mapping the shape of the particular patient'shead may be carried out manually, while in another embodiment, themapping the shape of the particular patient's head may be carried out bymapping means which are at least partially automated.

When the mapping the shape of the particular patient's head is carriedout by mapping means which are at least partially automated, the mappingmeans may include a computer.

When the mapping the shape of the particular patient's head is carriedout by mapping means which are at least partially automated, the mappingthe shape of the patient's head may include touchless sensing of theshape of the patient's head. The touchless sensing may involve the useof a camera or a laser sensor.

In an embodiment, the headgear may be a type of headgear having at leasttwo pieces of sheet material which are joined together, wherein theforming the headgear into a headgear shape in accordance with themapping includes forming each of the pieces into a respective sheetshape configured to enable the achievement of the headgear shape whenthe headgear is formed, and joining the pieces of sheet materialtogether in the forming of the headgear.

In another embodiment, the joining the pieces of sheet material togetherin the forming of the headgear includes joining the pieces of sheetmaterial along predetermined joint paths to define detachment areasadjacent the joint paths in which the pieces of sheet material aredetached from each other.

The joint paths may constitute lines of fold lines to facilitate curvingof the joined pieces of sheet material in the forming of the headgearinto the headgear shape.

Each joint path may be of a zig-zag configuration, and may besubstantially sinusoidal so as to define peaks and troughs.

In this case, adjacent pairs of the joint paths may be positionedrelative to each other so that each peak of one joint path of the pairis aligned with a respective trough of the other joint path and viceversa, whereby the detachment areas may be substantially diamond-shaped.

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIG. 1 is a perspective view of a headgear according to an embodiment ofthe invention, the headgear in a position of use;

FIG. 2 is a plan view of the headgear of FIG. 1 shown in a flattened-outcondition (i.e., not in a position of use);

FIG. 3 is a perspective view of another embodiment of the headgearviewed from another angle to that shown in FIG. 1;

FIG. 4 is a perspective view, shown partly in cross-section, of a nosepiece according to an embodiment of the invention;

FIG. 5 is schematic plan view of a nose piece according to anotherembodiment of the invention;

FIG. 6 is a schematic elevation of a conduit according to an embodimentof the invention, the conduit shown attached to an air supply;

FIG. 7 is a schematic perspective view of a cushion indicative of amanner of forming a headgear according to an embodiment of theinvention;

FIG. 8 is a schematic elevation of the cushion of FIG. 7 in a formedcondition;

FIG. 9 is a one way inflation nipple;

FIG. 9A is cross section through a portion of the nipple of FIG. 9;

FIG. 10 is a perspective view of a tube structure for connecting aheadgear to an air supply pipe;

FIG. 11 is a plan view of headgear similar to that of FIGS. 1 and 2,showing a strap system included with the headgear; and

FIG. 12 is a plan view of headgear similar to that of FIGS. 1 and 2,showing a collapsible cuff included on the ends of the conduits of theheadgear.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

Referring to FIGS. 1 and 2, there is shown a headgear 10 according to anembodiment of the invention. The headgear 10 includes a pair of conduitsor side portions 12 which are joined integrally to each other by acentral portion 14. A head attachment means in the form of a strap 16 isalso joined integrally to the side portions 12 as shown in FIG. 1, sothat the side portions 12, central portion 14, and strap 16 are all ofan integral, unitary construction.

The side portions 12, central portion 14 and strap 16 are formed byjoining together, e.g., by high-frequency (HF) plastics welding, a pairof polymeric (e.g., plastic) sheets 17. The manner in which the sheets17 are joined together is such that the middle portions of the sheets 17can be parted from each other to define passages running along thelength of the side portions 12, as described in more detail below. Itwill be appreciated that, when the sheets 17 are configured to form suchpassages in the side portions 12, the side portions 12 constituteconduits, and will be referred to as such below. The sheets 17 may bejoined together in any suitable manner to form such passages in the sideportions 12.

The conduits 12, at the positions where the sheets 17 are joinedtogether (e.g., by plastics welding), may be provided with inwardlyextending pleats (e.g., V-shaped recesses extending inwardly withrespect to the conduits) to facilitate the parting of the middleportions of the sheets 17 and hence the formation of the passages, asreferred to above.

The central portion 14 has an aperture 18 at the center thereof. Theheadgear 10 includes a T-connection or T-shaped connector 20 whichextends into the aperture 18. The T-connection 20 includes a pair ofside pipes 22 and a central pipe 24 which opens into the side pipes 22.The side pipes 22 extend, in opposite directions, between the plasticsheets 17, with the center pipe 24 protruding from the central portion14 via the aperture 18. The side pipes 22 are firmly engaged with theplastic sheets 17 so as to form a substantially air-tight seal with thesheets 17, while permitting some rotational movement between the sidepipes 22 and the sheets 17.

The positions of the ends 26 of the side pipes 22 (indicated in brokenlines in FIGS. 1 and 2) also serve to mark the transition from thecentral portion 14 to the respective side portions 12. Accordingly, thepositions of the conduits 12 corresponding to the ends 26 of the sidepipes 22 constitute first upper ends 28 of the conduits 12.

An attachment formation or swivel 30 which has a cylindrical union 32 atits end, is mounted around the center pipe 24 so as to be rotatablerelative to the center pipe 24. As discussed further below, theattachment formation 30 is for receiving the end (not shown) of an airsupply pipe leading from a flow generator or an air supply means (alsonot shown) for supplying air under pressure to the headgear 10, so as toconnect the air supply pipe in fluid-flow communication with the centerpipe 24 while permitting rotation of the air supply pipe.

In FIGS. 1 and 3, the headgear 10 is shown mounted on a patient's head34. As illustrated, the central portion 14 and T-connection 20 of theheadgear 10 are configured to extend across the patient's head 34 at aposition somewhat anterior of the apex 36 of the head 34, while thestrap 16 is configured to extend around the portion of the head 34posterior of the apex 36. The headgear 10 is designed to conform to thecurvature of the occiput of the patient's head 34 so that the headgear10 is stably seated thereon.

Also, as can be seen in FIGS. 1 and 3, the conduits 12 extend downwardson opposite sides of the patient's head 34 between the eye and ear 38 ofthe patient on each side of the head 34. The conduits 12 curve forwardstowards their lower extremities, to terminate at second ends 40 (seeFIG. 1) that are opposite to the first ends 28. The second ends 40 areadjacent to the patient's nose 42 and may be attached to a nasalinterface, such as the nose piece 150 referred to below (see FIG. 3)which is in contact with the patient's nose.

As shown in FIG. 1, attached to the second end 40 of each conduit 12 isa nose attachment formation or nasal interface connector 44, having apart which extends via the respective second end 40, between the plasticsheets 17, to a position (not shown) within the conduit 12, and anotherportion 46 which is outside the conduit 12.

Each portion 46 of the nose attachment formation 44 is configured as asocket for receiving complementary formations (not shown) which areconnected to nose pieces 150 as discussed below.

In the illustrated embodiment, the sheets 17 are flocked (e.g., have avelvet-like texture) to provide comfort to the patient, and theirattachment to each other is reinforced by stitching 52 (see FIG. 1). Theheadgear 10 may also be provided with a cover (not shown) of cloth orother material which will be comfortable to a patient, and the cover mayhave decorative effects, e.g., patterns or other markings, which may beattractive to a child patient.

A thin layer of foam rubber or other suitable padding (not shown) may beprovided in selected locations between the inner surfaces of the sheets17 to enhance the structural integrity of the headgear 10, or otherwiseimprove comfort to the patient especially on the bony regions of theface, e.g., the cheekbones.

Referring now to FIG. 4, the nose piece 150 is discussed in more detail.The nose piece 150 includes a conduit 152 having outer walls 154. Theouter walls 154, in turn, are double walls, having inner wall portions156 and outer wall portions 158. The inner wall portions 156 and outerwall portions 158 are sealingly joined to each other at first and secondends 160 and 162, respectively, of the nose piece 150. Each end 160 and162 is configured for connection in fluid flow communication to theportion 46 of a respective nose attachment formation 44.

The inner wall portions 156 and outer wall portions 158 define, betweenthem, an annular space 164 extending circumferentially with respect tothe nose piece 150.

The conduit 152 defines a pair of apertures 166 each for accommodating arespective nostril formation 168 of flexible plastic or elastomer (e.g.,silicone rubber) which extends through the relevant aperture 166. Eachnostril formation 168 has a central passage 170. The nostril formations168 are shaped to provide a close comfortable fit in the patient's nose42, i.e., in the patient's nostrils. The nostril formations 168 may haveany suitable form, e.g., nasal pillows, nasal prongs, cannula, or nasalpuffs. If desired, the nostril formations 168 may be shaped and sized soas to be customized to a particular patient's nose.

The outer walls 154 of the nose piece 150 define a central passage 172for establishing fluid flow communication between the interiors of theconduits 12 and passages 170 of the nostril formations 168, and hencewith the patient's nose 42.

Similar to the headgear 10, the conduit 152 may be formed from sheets ofpolymeric (e.g., plastic) material which may be suitably joined by HFplastics welding to achieve the construction represented in FIG. 4.

Opening through the outer wall portion 158 of each nose piece 150, intothe respective annular space 164, is an inflation nipple 175 having aone-way valve 174 which is illustrated in more detail in FIGS. 9 and 9A.The nipple 175 and one-way valve 174 permit the introduction of air intothe annular space 164 so as to inflate the conduit 152 to provide itwith sufficient rigidity to maintain its shape, while not depriving itof sufficient flexibility so as to be uncomfortable to the patient. Thenipple 175 and valve 174 can thus be used to introduce more air into, orto remove air from, the annular space 164 so as to allow the rigidity orsize of the conduit 152 to be adjusted to suit a particular patient orparticular circumstances.

The nipple 175 may include a short tube 302. The nipple 175 includes abase 304 below the short tube 302, the base being joined, e.g., byplastics welding, to the nose piece 150 (or to the headgear 10 in thecase of the headgear 10 being inflatable). The plastic material of thebase 304 may be thinner than that of the remainder of the tube structure300. This allows for twisting of the short tube 302 as represented inphantom lines, and by the arrow 305, in FIG. 9. The base 304 also isnear the one way valve 174 as described below.

The nipple 175 also includes a cap 306 receivable as a tight butremovable fit in the short tube 302 for closing off the short tube 302and preventing the passage of air through it. As illustrated, a flexiblecord 308 joins the cap 306 to an upper side position of the short tube302. The flexibility of the cord 308 allows the cap 306 to be movedbetween its closure condition as shown in which it closes the short tube302, and an open condition in which it is removed from the opening ofthe short tube 302.

The nipple 175 is also provided with an upper waist region 310 and alower waist region 312 which is narrower that the upper waist region310. These waist regions allow deformation of the nipple 175 bypermitting the lower waist region 312 to be telescopically receivedwithin the upper waist region 310. This, in turn, allows the nipple 175to be pressed into that portion of the nose piece 150 (or headgear 10 ifthe headgear 10 is inflatable) to which it is joined so that it becomesinverted within that portion, and effectively stowed away.

As described above, the base 304 of the nipple 175 is near the one wayvalve 174, which has a moveable flap 174.1. The moveable flap 174.1extends from and is hinged to, and formed integrally with, the internalwall of short tube 302. The one way valve 174 includes a flange 174.4which serves the purposes of a detent to prevent the flap 174.1 movingpast the flange 174.4 in the direction of arrow 174.2, when the cavity174.5 is under pressure. The flange 174.4 also provides a location forthe edge of the flap 174.1 to seal against.

When the cavity 174.6 has a greater pressure therein than the cavity174.5, e.g., when it is being inflated, the flap 174.1 will move in thedirection of arrow 174.3 allowing inflation. As soon as there is apressure differential, the flap 174.1 will move to a closed position,thereby acting as a one way valve. To deflate via the nipple 175, theuser need only deform nipple 175 by compressing or squeezing the sidesin the region of the one way valve 174, whereby the deformation willbreak the seal with the flange 174.4 allowing deflation.

In another embodiment, the nostril formations 168, instead of beingseparate formations of rigid plastic, may be integral with the conduit152. In such an embodiment, the apertures 166 may be omitted.

In one form of this embodiment, the nostril formations 168 may haveouter wall portions and inner wall portions which may be continuous withthe outer wall portions 158 and inner wall portions 156, respectively,of the conduit 152, and which define between them a space which may becontinuous with the annular space 164. Thus, inflation of the conduit152 may also cause inflation of the nostril formations 168.

In a further embodiment as shown in FIG. 3, the nose piece 150 may beintegral with the conduits 12 so that the headgear 10 and conduit 152are of a unitary construction. In one form of this embodiment, thenostril formations 168 may be rigid plastics formations received inapertures 166 of the conduit 152. In another form of this embodiment,the nostril formations 168 may be integral and continuous with theconduit 152 as described above.

In another embodiment as shown in FIG. 5, instead of having a nose piecewhich includes a conduit such as the conduit 152 and nostril formationssuch as the nostril formations 168, two inflatable curved nostrilformations 176 (only one being shown) may be provided. In theillustrated embodiment, each nostril formation 176 has outer wallportions 178 and inner wall portions 180 defining a central enclosedannular space 182 between them, a one-way valve 184 for introducing airto the space 182 to inflate the nostril formation 176, and a centralpassage 186. In this embodiment, one end 188 of each nostril formation176 is configured for attachment to the portion 46 of a respective noseattachment formation 44, while an opposite end 190 is configured forbeing received in the patient's nose 42. In an embodiment, the nostrilformations 176 for each of the patient's two nostrils may be adapted tobe attached to each other, to facilitate support of the nostrilformations 176 and their sealing with the patient's nose.

In other embodiments, the nose pieces 150 or conduits 152 thereof may beother than the inflatable constructions as described above. They may,instead, have single outer walls of similar construction to the conduits12.

For example, the nasal interface may be structured similar to nasalassemblies disclosed in U.S. patent Ser. No. 10/781,929, which isincorporated herein by reference in its entirety.

Alternatively, the conduits 12, instead of having their walls formed ofsingle plastic sheets as described above, may be made up of double wallshaving inner wall portions and outer wall portions similar to the innerwall portions 156 and outer wall portions 158, respectively, of the nosepiece 150. These inner and outer wall portions would define a sealed andinflatable inner space similar to the space 164 of the nose pieces 150.

This construction of double walls may be used for the whole of theheadgear 10, or selected portions of it. This would enable selectedportions of the headgear 10, which are inflatable as a result of thedouble wall construction, to be inflatable as in the case of theconduits 152 of the nose piece 150, to achieve a desired amount ofrigidity where required. The double wall construction would also serveto reduce noise transferred through the walls.

In one embodiment, an inner skeleton may be provided in some or allparts of the above equipment where such double walls are provided in thecavity between the relevant inner and outer wall portions. The innerskeleton may be comprised, for example, of spring wire, and this couldbe configured in an expanded condition to provide further structuralsupport where the skeleton is used.

In use, as described in relation to FIG. 1, the headgear 10 is placed onthe head 34 of the patient. The T-connection 20 is connected to a supplypipe (not shown) of an air supply (also not shown) configured forsupplying air under a positive pressure. The supply pipe will include anend for attachment to the attachment formation 30 for effecting a sealwith the T-connection 20.

In another embodiment or in combination with the embodiment describedabove, a suitable structure may be provided for minimizing the extent towhich the supply pipe pulls on the headgear 10. This structure mayinvolve a pivotable pipe connection, a ball-and-socket connection, or aflexible bellows connection (such as that described in the nextparagraph) to the T-connection 20, or to another part of the relevantheadgear in an embodiment where there is no such T-connection. This mayfacilitate stability of the headgear 10 by reducing the extent to whichdrag forces on the supply pipe are transferred to the headgear 10.

The attachment formation 30 may include a concertina tube 300 asillustrated in FIG. 10, which terminates in a cylindrical union 32. Thetube 300 may allow for relative rotation of the air supply couplingthereby preventing the transfer of bending forces which would otherwiseuncouple the air supply connection.

The supplied air passes into the central pipe 24 of the T-connection 20and then via the side pipes 22 into the conduits 12. As the air is undera positive pressure, it serves to inflate the conduits 12 so that theydefine central passages extending from their respective first ends 28 totheir respective second ends 40. The air then passes via the noseattachment formations 44 and nose piece 150, into the patient's nose 42(i.e., the nostrils).

The headgear 10 may be custom fit to a particular patient's head 34.This may be achieved by scanning or mapping the head 34 to determine itsshape in a three-dimensional sense, and then cutting the sheets 17 sothat when the sheets 17 are joined to each other they form a headgear 10which is suitable for achieving a close and comfortable fit on thepatient's head 34. It will be appreciated that there may be as manydifferent shapes of the headgear 10 as there are patient's heads 34. Inaddition, once a particular shape is determined in which to form a sheet17 in relation to a particular patient's head, or in relation to aparticular type of head shape (which may apply to more than onepatient), there is no limitation on the number of sheets that may be cutto a particular sheet shape to form a particular headgear.

In an embodiment, the sheets 17 may be joined along predetermined jointpaths. In this regard, reference is made to the cushion 200 shown inFIGS. 7 and 8, which has two sheets 202 (only one being shown) joinedalong paths 204. It will be seen that the paths 204 are of a sinusoidal,zig-zag shape with peaks 206 and troughs 208 such as may be found inquilting-like formations. The troughs 208 of each path 204 are alignedwith the peaks 206 of the next path and vice versa, so as to formsubstantially diamond-shaped areas 210 between the paths where thesheets 202 are not connected to each other. In an embodiment of theheadgear 10 under discussion, the headgear 10 may be formed with thesheets 17 being joined to each other in a similar fashion to the sheets202, with the paths serving as fold lines to facilitate curving of thejoined sheets 17 (as represented by the curving of the cushion 200 inFIG. 8) to conform to the shape of the head 34.

The regions of the headgear 10 corresponding to the diamond-shaped areas210 of the cushion 200 may be inflated to form a number of juxtaposedcushioned zones to provide added comfort to the patient and tofacilitate the firm and even seating of the headgear 10 on the patient'shead 34.

Alternatively, instead of using the mapping to determine the shape inwhich the sheets 17 are to be cut as described above, the mapping may beused to form part of a headgear by forming a thermoplastic polymer inthe shape of the patient's head 34.

The shaping of the headgear 10 to suit the particular shape of apatient's head 34 may significantly assist in achieving a headgear 10having conduits 12, a central portion 14, and a strap 16 which aresnugly fitted to the patient's head 34. This may achieve an effectivedistribution of pressure between the headgear 10 and the patient's head34 rather than having specific locations at which there are highpressure points and other locations at which there is insufficientpressure. This, in turn, facilitates the secure attachment of theheadgear 10 to the patient's head 34.

In addition, the unitary construction of the conduit 12, central portion14 and strap 16, with the headgear 10 being specifically suited to aparticular patient's head 34, eliminates the need for adjustment partsof the headgear 10 which would otherwise be required to fasten theheadgear 10 securely to the patient's head 34. This unitary constructionalso simplifies the donning of the headgear 10 and removal thereof fromthe patient's head.

The snug securing of the headgear 10 to the patient's head 34 may befurther facilitated in those embodiments of the headgear 10 havingdouble walls, or portions with double walls as referred to above. Inthese embodiments, inflation of the double walls (i.e., provision ofinflating air into the space between the double walls) causes therespective inner wall portions to press more firmly against thepatient's head 34. This can be particularly useful in relation to thoseparts of the patient's head 34 which are of a substantially concave orrecessed shape, such as immediately in front of the patient's ears 38.

With the nose piece 150 being joined to the conduits 12 as describedabove, the air supplied into the center pipe 24 of the T-connection 20,after having passed through the passages of the conduits 12, proceeds topass along the passage 166 of the conduit 152 of the nose piece 150, andinto the patient's nose 42.

Exhalation by the patient is facilitated by using a material for theplastic sheets 17 which is to some extent gas permeable, preferably inthe vicinity of the nose 42 of the patient. This will allow for acertain amount of leakage or venting of air and exhaled carbon dioxidetherethrough. A suitable thermoplastic elastomer, e.g., a poly-olefin,may be used for this purpose. Alternatively, the sheets 17, instead ofbeing fully of plastic, may be wholly, or may have parts, made of othertypes of gas permeable material, e.g., silk or other woven material, orthe Polytetrafluoroethylene (PTFE) material known as GORETEX®.

As the patient breathes out, the exhaled breath can then pass via thenose pieces 150 and then through the walls of the conduits 12 atpositions close to the respective second ends 40 thereof.

A particularly suitable material for the sheets may be breathablepolyurethane which allows the passage of water vapour with the escapingair, but provides a substantially airtight passage. By the expression“substantially airtight,” it is meant that sufficient resistance to thepassage of air therethrough is provided to prevent too much air fromescaping. The ability to allow water vapour to pass through isadvantageous as it may assist in avoiding an undesirable accumulation ofmoisture originating from gases exhaled by the patient, in the interiorpassages of the conduits 12. Materials that may provide these propertiesinclude those manufactured by the Darlington Corporation known by thetrademark DARLEXX®, or the 3M product known by the trademarkTHINSULATE®, or the Polytetrafluoroethylene (PTFE) material known asGORETEX®, or the product known as ATLANTECH™ made by Atlantis WeatherGear Inc.

With the walls of the conduits 12, or parts thereof, being gas permeableas described above, some of the air supplied via the center pipe 24 ofthe T-connection 20 will also escape from the conduits 12. Thisarrangement and the flexible nature of the passageways can assist in areduction in the noise generated by the passage of air via the conduit12 to the nose pieces 150.

The passage of exhaled gas through the walls of the conduits 12 may alsoprovide a useful means for allowing heat to escape from the headgear 10.Such heat, if not allowed to escape in this manner, may result in theheadgear 10 becoming so heated as to be unnecessarily uncomfortable forthe patient. In addition, the gas permeability of the materials used, asreferred to above, may permit the passage of heat and water vapourthrough the parts of the headgear on top of the patient's head 34 toimprove comfort, especially in warmer weather. The construction of theheadgear 10, and particularly its unitary nature, has the advantagethat, if the headgear 10 is being worn by the patient, and the patientrolls his or her head 34 onto a surface such as a pillow so that one ofthe conduits 12 is flattened by the pressure of the patient's head 34 onthe pillow, all or most of the air that would have passed through thatconduit 12 but which is prevented from doing so due to the constrictionof the conduit's passage is permitted to pass instead through the otherconduit 12. This is enabled due to the flexibility of the conduits 12and their resultant ability to expand and substantially collapse. Thus,the total volume flow rate of the air through the pair of conduitsremains substantially constant during the flattening and expansion ofthe respective conduits. Depending on the configuration andcross-sectional shapes of the conduits 12 when the above flattening andexpansion occurs, the collapsing of the conduit 12 causes a change inthe ratio between a height extent and a lateral extent of that conduit,with the height extent decreasing and the lateral extent increasing.Similarly, the deformation of the other conduit causes a change in theratio between its height extent and lateral extent with the heightextent increasing and the lateral extent decreasing.

In an embodiment, the headgear may include an adjustable head cap withthe conduits being attached to the cap at opposite sides thereof. Inthis case, the cap may constitute the attachment means, and theconnection means may be mounted on the cap.

In another embodiment, the conduits may be detachable from theattachment means so that the attachment means may be selectivelyreleasably connected with differently sized and/or shaped conduits. Inthis case, the conduits may be selectively releasably connected withdifferently sized and/or shaped attachment means, whereby the headgearmay form part of a modular headgear system having interchangeableattachment means and conduits.

In yet another embodiment, the headgear may be adapted for use with apatient mask, the mask being configured to fit the patient's headadjacent the patient's nose to direct gas from the conduits to the nose.Then, the headgear may be adapted to be detachable from the mask toenable the patient to selectively remove the mask from the headgear andhence from the patient's head while the headgear continues to be beingworn by the patient.

A particular advantage of the headgear 10 as described is that, when notin use, the T-connection 20 may be removed from the aperture 18. Then,the conduit 12, the central portion 14, and the strap 16 may beflattened out so as to collapse the passages of the conduits 12, androlled up or folded for storage purposes, so that a minimum of storageroom is required. On the other hand, when in use, the passage of airitself through the conduits 12 serves to inflate the passages and topress the inside walls of the conduits 12 firmly against the sides ofthe patient's head 34 to achieve a comfortable and snug fit.

The headgear 10 has various advantages. For example, an advantage of theheadgear 10 is that the T-connection 20 is located in use at a positionof the patient's head which is unlikely to be subjected to anycompression force due, for example, to the patient's head being on apillow. Thus, while the conduits 12 are flexible and should thereforenot provide much discomfort to the patient even if the patient lies onthem, this should not be an issue in respect of the relatively hardT-connection 20, due to the location of this component.

In addition, the relative flexibility and hence softness of the materialfrom which the conduits 12, the central portion 14 and strap 16 areformed allows the headgear 10 to be engaged with parts of the patient'shead, such as the patient's cheeks, that may have been too sensitive forengagement with prior art devices.

The fact that the conduits 12 and central portion 14 define most of thepassageways through which air needs to travel to be delivered to thepatient means that the need for additional tubing and tubing securementstraps may be avoided. Therefore, this also avoids the bulk and weightthat such additional tubing and securement straps might involve.

The ability of one of the conduits 12 to expand to allow for a greatervolume flow rate when the other conduit 12 is compressed or collapsed soas to be generally flat against the patient's face (e.g., when thepatient lies on the other conduit 12 on a pillow) enhances the patient'scomfort and minimizes discomfort that might have been caused if moreinflexible tubing were used. It also reduces discomfort that may becaused by engagement of the headgear 10 with contact pressure points onthe patient's head 34.

The use of plastics welding as described above for manufacturing theheadgear 10 avoids the need for clips, buckles, adjustment straps andthe like, thus providing for greater simplicity of use. In addition, theforming of the headgear 10 to suit the shape of the patient's head 34and the inherent lightweight nature of the headgear 10 assists inproviding greater comfort to the patient.

Referring to FIG. 6, there is shown a schematic representation of a PAPmachine conduit 400 according to an embodiment of the invention. Theconduit 400 has flexible conduit walls 402, and has a first end 404 anda second end 406. The first end 404 is attached to a supply means 408for supplying air under a positive pressure. As in the case of theconduits 12 described above, the conduit 400 is collapsible. As airunder a positive pressure is supplied by the supply means 408, thepressure of the air urges the walls 402 into the condition shown, inwhich the walls 402 define a central passage 410 of the conduit 400.Thus, the air may pass along the passage 410 to the second end 406,where the air may be directed as required.

As an alternative to the walls 402 being urged into the condition shownonly by the pressure of the air, a collapsible spring may be providedwhich assists in preventing kinking of the conduit 400 in use.

The flexibility of the walls 402 allows the conduit 400 to be folded orrolled to a compact size during storage or travel. In addition, thesewalls may be of a single wall type or a double wall type similar to thewalls 154 described above. Such a double wall construction may alsoprovide enhanced insulation to assist in regulating the temperature ofthe air from the air supply means 408.

Illustrated in FIG. 11 is headgear 1010, which is similar to theheadgear 10 of FIGS. 1 and 2, and accordingly, like parts have been likenumbered. The headgear 1010 differs from the headgear 10 in that twostraps 1012 are provided, each of which is connected to and extends froma respective one of the conduits or side portions 12 of the headgear 10.The straps 1012 respectively terminate in buckle members 1014 and 1016which can connect to a mask or nose piece and allow a user to secure theheadgear 1010 to his or her head. The straps 1012 may provide foradjustability of the strap length.

Illustrated in FIG. 12 is headgear 1110, which is similar to theheadgear 10 of FIGS. 1 and 2, and accordingly, like parts have been likenumbered. The headgear 1110 differs from the headgear 10 in that acollapsible cuff 1112 is provided on ends of each of the conduits orside portions 12. As illustrated, the collapsible cuff 1112 is of abellows formation. The collapsible cuff 1112 allows the length of theends of the conduits 12 to be adjusted by extension or contraction, asrequired.

It will be understood that the invention disclosed and defined hereinextends to all alternative combinations of two or more of the individualfeatures mentioned or evident from the text. All of these differentcombinations constitute various alternative aspects of the invention.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. In addition, while the invention has particularapplication to patients who suffer from OSA, it is to be appreciatedthat patients who suffer from other illnesses (e.g., congestive heartfailure, diabetes, morbid obesity, stroke, bariatric surgery, etc.) canderive benefit from the above teachings. Moreover, the above teachingshave applicability with patients and non-patients alike.

What is claimed is:
 1. A nasal assembly for delivering breathable gasunder positive pressure to a patient for treatment of sleep disorderedbreathing, the nasal assembly comprising: an air connector configured tobe connected to a supply of breathable gas, the air connector beingadapted to be positioned on top of the patient's head when the nasalassembly is worn; a nasal interface configured to engage the patient'snose to direct the breathable gas to the patient's nose; a pair offlexible one-piece side portions configured to support the nasalinterface in a desired position on the patient's face and to deliver thebreathable gas to the nasal interface in use, each side portionproviding a conduit having a top portion in fluid communication with theair connector and a bottom portion adapted to, in use, be positionedadjacent the patient's nose, each conduit being arranged to, in use,extend along a respective side of the patient's head between thepatient's eye and ear; a central portion integrally formed with the pairof side portions to join the top portions of the conduits, the centralportion and the pair of side portions forming a unitary construction;and a strap including a portion that extends from one of the sideportions to the other one of the side portions and is adapted to engagethe back of the patient's head at a point above the patient's ears whenthe nasal assembly is worn, the portion of the strap being connecteddirectly to each of the side portions, wherein each conduit isconfigured to collapse into a collapsed condition under the weight ofthe patient's head, and wherein the air connector is attached to thecentral portion, the air connector being relatively rigid as compared tothe pair of side portions and the central portion.
 2. The nasal assemblyof claim 1, further comprising an aperture formed in the centralportion, the air connector extending into the aperture.
 3. The nasalassembly of claim 1, wherein the air connector enables movement of thecentral portion with respect to an air supply tube to reduce tube drag.4. The nasal assembly of claim 3, wherein the air connector comprises aswiveling device.
 5. The nasal assembly of claim 1, wherein the centralportion is arranged such that the air connector is adapted to bepositioned anterior of an apex of the patient's head when the nasalassembly is worn.
 6. The nasal assembly of claim 1, wherein the pair ofside portions is shaped to match a contour of the patient's head.
 7. Thenasal assembly of claim 1, further comprising a vent adapted to bepositioned in the vicinity of the patient's nose, in use, to allowexhaled carbon dioxide to pass to atmosphere.
 8. The nasal assembly ofclaim 1, wherein each conduit comprises a conduit wall that isdeformable between (a) an open condition in which the conduit walldefines a conduit passage along which the breathable gas can travel fromthe top portion to the bottom portion, and (b) a collapsed condition inwhich the conduit wall substantially collapses the conduit passage. 9.The nasal assembly of claim 8, wherein each conduit is configured toaccommodate an increase in volume flow rate of breathable gas throughthe conduit when the conduit passage of the other conduit is in thecollapsed condition.
 10. The nasal assembly of claim 9, wherein theconduits are configured such that a total volume flow rate of breathablegas through the conduits remains substantially constant even if one ofthe conduits is deformed into the collapsed condition.
 11. The nasalassembly of claim 1, wherein the strap is joined to the conduits. 12.The nasal assembly of claim 1, wherein the strap is formed integrallywith the conduits.
 13. The nasal assembly of claim 1, wherein theconduits comprise an elastomer.
 14. The nasal assembly of claim 1,further comprising a nasal interface connector attached to the bottomportion of each conduit, each nasal interface connector being removablyconnected to a respective side of the nasal interface.
 15. The nasalassembly of claim 14, wherein each nasal interface connector includes aconnection portion that extends from the respective conduit to connectwith the nasal interface.
 16. The nasal assembly of claim 15, whereinthe nasal interface includes two complimentary formations on opposingsides thereof to mate with the connection portion of a correspondingnasal interface connector.
 17. The nasal assembly of claim 1, furthercomprising: an aperture formed in the central portion, the air connectorextending into the aperture, wherein the air connector enables movementof the central portion with respect to an air supply tube to reduce tubedrag, wherein the central portion is arranged such that the airconnector is adapted to be positioned anterior of an apex of thepatient's head when the nasal assembly is worn, wherein each conduitcomprises a conduit wall that is deformable between (a) an opencondition in which the conduit wall defines a conduit passage alongwhich the breathable gas can travel from the top portion to the bottomportion, and (b) a collapsed condition in which the conduit wallsubstantially collapses the conduit passage, wherein each conduit isconfigured to accommodate an increase in volume flow rate of breathablegas through the conduit when the conduit passage of the other conduit isin the collapsed condition, and wherein each conduit is configured todeform into the collapsed condition under the weight of the patient'shead.
 18. The nasal assembly of claim 1, wherein the air connectorcomprises a swivel coupling device to connect to an air supply conduit,the swivel coupling device being rotatable relative to the airconnector.